NCT04696250

Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy (AVATAR)

Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy : an Observational and Retrospective Study Using the WHO Pharmacovigilance Database(AVATAR)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000,000 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 100 Years
• Healthy volunteers: Not accepted

Summary

Anticancer drugs can lead to various adverse events. This study analyses reports of adverse events for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Detailed description

The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse events following treatment with antineoplastic agents, endocrine therapy, immunostimulants or immunosuppressants drugs.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Antineoplastic and Immunomodulating Agents	Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-01-01
• Completion: 2025-01-01
• First posted: 2021-01-06
• Last updated: 2021-01-06

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study